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FDA 510(k) Application Details - K150032
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
510(K) Number
K150032
Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Applicant
GLUSTITCH, INC.
#307-7188 PROGRESS WAY
DELTA V4G 1M6 CA
Other 510(k) Applications for this Company
Contact
DON BLACKLOCK
Other 510(k) Applications for this Contact
Regulation Number
878.4010
More FDA Info for this Regulation Number
Classification Product Code
MPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/08/2015
Decision Date
01/14/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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